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Transition of Paxlovid to Commercial Distribution

November 28, 2023

Update on Sunsetting Guidance

The guidance on returning product and other elements of the transition to commercialization have been updated. For full details, please see Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program.

As part of the transition from government-managed distribution to commercial distribution of COVID-19 oral antivirals, Paxlovid thresholds were set to zero as of November 27. Providers in need of additional treatment courses as commercial distribution ramps up should submit out of cycle requests. Out of cycle requests take up to 48 hours to process, and orders are made against those requests. Out of cycle requests should be received 48 hours in advance to allow sufficient time to process an out of cycle request so that orders can be placed. USG-procured Paxlovid must continue to be accounted for in the Health Partner Ordering Portal (HPOP).

Paxlovid ordering from the USG supply closes at 3 p.m. ET, Friday, December 15 except for the following federal entities: Health Research and Services Administration, Department of State, Indian Health Service, Peace Corps, Bureau of Prisons, Immigration and Customs Enforcement, National Institutes of Health, Department of Defense and Veterans Affairs; these federal departments and agencies can continue to order USG-procured supply.

USG-distributed, EUA-labeled packages of Paxlovid with an expiration date of December 2023 or later are eligible to be returned via the Pfizer return process. Returns will be accepted through December 31, 2023, and count as a credit toward the USG-procured inventory. We recommend that returns occur after NDA-labeled inventory is secured, the USG PAP operated by Pfizer is live, and commercial payer coverage is established. Returned courses will be replenished as NDA-labeled supply to support the USG PAP operated by Pfizer and federal entities.

The Paxlovid co-pay assistance program is available for patients with commercial insurance. Patients can find information and download co-pay savings cards at Paxlovid.com. Providers can find information and download co-pay cards for patients using Paxlovid.pfizerpro.com.

With an anticipated start date of December 1, 2023, through December 31, 2024, individuals covered under federal programs, such as Medicare or Medicaid, and uninsured patients are eligible for the USG PAP and can receive Paxlovid at no cost. Health care providers and dispensing locations can provide information to patients regarding eligibility and how eligible patients can enroll in the PAP to obtain free product. Through this program, participating USG PAP dispensing sites will be reimbursed for any product dispensed, along with a dispensing fee. Retail pharmacies that would like to learn more about participating in the USG PAP can contact the program vendor at PharmacyNetworkContract102101@assistrx.com.

To assist in the transition from government-managed to commercial distribution, ASPR has frequently asked questions (FAQ) posted on the COVID-19 therapeutics website, and an updated therapeutics transition guide, Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program. We will continue to update the guide and the FAQ as more details become available.

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